BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT (CONVENIENCE KIT)

    MDR report key: 1942720 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06422
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 8, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K081289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. THE SAMPLE WAS ATTACHED TO AN IN-HOUSE PRIMARY SET WHICH WAS SPIKED INTO A 1000ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER AND THE SET-UP WOULD NOT PRIME. A VISUAL INSPECTION OF THE GLAND UNDER A MICROSCOPE REVEALED A RE-KNIT CONDITION OF THE CENTER SLIT. A SECOND PRIMING ATTEMPT PASSED WITH NORMAL FLOW NOTED. BASED ON THE EVALUATION RESULTS THE CONDITION WAS CONFIRMED. THIS CONDITION WAS CAUSED BY RE-KNIT OF THE CENTER SLIT. THERE IS NO 510K NUMBER ASSOCIATED WITH THIS PRODUCT AS IT IS 510K EXEMPT. HOWEVER, THE INDIVIDUAL COMPONENT FROM THE KIT WITH THE REPORTED DEFECT HAS A 510K NUMBER. THEREFORE, IN THIS MDR, THE 510K NUMBER UTILIZED IS REFERRING TO THE SPECIFIC COMPONENT OF THE KIT RELATING TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A VITALHOLD STANDARD BORE EXTENSION SET WITH V-LINK CATHETER SECUREMENT (CONVENIENCE KIT) THAT WOULD NOT ALLOW FLOW THROUGH THE V-LINK AFTER THE SOLUTION BAG WAS SPIKED. THE CUSTOMER WAS USING A CONTINU-FLO 109" INCH PRIMARY SET IN CONJUNCTION WITH THE V-LINK EXTENSION SET. THE CONDITION OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT (CONVENIENCE KIT) INTRAVENOUS EXTENSION TUBING SET FPA BAXTER HEALTHCARE R09L08018

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTINU-FLO 109" INCH PRIMARY SET